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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Ireland Offers to Waive Certain Fees to Ease Impact of Brexit

Ireland is offering to waive the fee for certain Brexit-triggered regulatory requests. The offer will allow companies to change their reference member state (RMS) from the United Kingdom to Ireland for free.

Officials from the Health Products Regulatory Authority (HPRA) of Ireland made the offer in guides on Brexit and fees published on either side of the turn of the year. The Brexit guide, like those produced by the European Medicines Agency (EMA), assumes the UK will become a third country in March 2019, a scenario that could be avoided if a softer exit or transitional agreement are achieved.

Based on HPRA’s assumptions, companies with products approved under the mutual recognition and decentralised procedures that currently use the UK as their RMS will need to transfer their record to an agency based in the European regulatory network. If more than one concerned member state (CMS) is associated with a product, the company will get to choose its new RMS.

Ireland wants companies to choose it as their new RMS. The agency’s pitch is partly financial. HPRA will not charge companies fees for moving the RMS from the UK to Ireland. The agency has also taken other steps to show it is “very willing” to become the RMS for products for which it is already a CMS.

“The HPRA commits to an efficient and simple process for handling these requests (for example allowing the inclusion of multiple products in one request where applicable) and for taking on the role of RMS,” the agency wrote in its Brexit guidance.

HPRA is asking companies that want to take it up on its offer to contact it as soon as possible to “plan work volumes and to ensure continuation of product supply on the EU market prior to the UK’s exit from the EU.”

As with other Brexit-triggered regulatory requests, part of the challenge stems from the need to fit the process in around day-to-day activities and get it finished by March 2019. The change in RMS can only happen when no other regulatory activities are open. Given such windows tend to be short, the Irish agency is proposing to complete transfers “within a matter of days.”

HPRA has put together a similarly streamlined process for companies that want to transfer marketing authorizations from the UK to Ireland. The agency is offering “reduced fees” and bulk transfers based on one application form to these companies.

France Targets 80% Biosimilar Penetration by 2022

France has committed to increasing biosimilar penetration to 80% by 2022. Hitting the goal would mean sales of innovative biologic products would be largely wiped out by the arrival of biosimilar competition.

The French government made the commitment to biosimilars — and detailed plans to increase use of generics — in its health strategy for the next four years. France has tried to move aggressively to promote biosimilars in the past, notably by including provisions for pharmacy-level substitution in its 2014 budget. Yet, the government is dissatisfied with the pace at which copycats are taking market share from innovative products, be they small molecules or biologics.

The 2018 to 2022 is light on details about the levers the French government will pull to hit its 2022 goal for biosimilar uptake. Some possible drivers of the increase in penetration are already in place. Last year, France changed its substitution policy, created a biosimilar registry and 11 groups of similar biologics and published penetration objectives.

Those objectives included the goal that, when biosimilars are available, 70% of patients initiating treatment should be given the copycat rather than the reference product. The document also encouraged the switching of patients already on treatment. France has now gone a step further and increased its overall biosimilar penetration target to 80%.

While France is seeking to cut the market share of off-patent biologics, its 2018 to 2022 strategy also commits to ensuring patients have access to new, innovative treatments. The caveat is that this must not affect the sustainability of health insurance expenses. France also wants to make sure it gets value from the drugs it does reimburse, and as such plans to step up its monitoring of the efficacy of newly available treatments.

EMA Sees 31% Year-on-Year Drop in Orphan Drug Designations

The number of orphan drug designations fell by 31% last year. That sharp drop marked the first time the number of orphan drug awards has fallen since 2013, and the lowest annual number since the same year.

EMA’s Committee for Orphan Medicinal Products (COMP) awarded 144 orphan drug designations last year, down from 209 in 2016. The last time the number of designations awarded fell was 2013, when COMP handed out 136 orphan drug statuses, 12 fewer than in 2012. From 2014 to 2016, COMP awarded at least 187 orphan drug designations a year.

Thelarge numbers of orphan drug designations awarded in recent years are yet to translate into a rise in the number of drugs approved to treat rare diseases. The annual number of designations in recent years is three to four times the levels seen in the early 2000s. Yet, the number of orphan drugs approved each year has been stuck at 14 since 2014. That is more than were approved in the early 2000s, although in the case of 2007, when 13 rare disease drugs were approved, the gap is slight.

These figures and other issues will factor into an upcoming review of orphan drug legislation by the European Commission. The Commission is looking at the topic through the lens of pediatric rare diseases, but its assessment will entail a review of whether the orphan drug legislation has met its goals and patients’ needs, plus an analysis of the effects of the incentives it offers.

Denmark Relaxes OTC Drug Rules, Posts new Guidance

The Danish Medicines Agency (DKMA) has relaxed its rules on the sale of certain over-the-counter (OTC) products. DKMA is now allowing shops to put some OTC products on shelves accessible to the public, rather than making them store the treatments behind the counter or in locked cabinets.

Stores must comply with rules intended to minimize the potential downsides to making OTC products more accessible to the public. DKMA expects staff to supervise the drugs and display them apart from other non-therapeutic products. The rules also task stores with placing OTC drugs at least 140 cm off the ground, a provision intended to keep them out of the reach of children.

DKMA is requiring that some OTC products continue to be kept behind the counter or in locked cabinets.

The revised rules for human OTC products came into force at the start of 2018. Efforts to make similar changes to the sale of veterinary products are lagging slightly behind. DKMA released a draft list of products it thinks are suitable for sale on store shelves and the criteria it used to select them this week. The agency is accepting feedback on the list until 10 January.